Goverment extends Schedule M implementation deadline for small, medium pharma firms till Dec 31
The Ministry of Health & Family Welfare has extended the due date for implementation of revised Schedule M -- good manufacturing practices provision, for small and medium pharmaceutical firms with turnover of Rs 250 crore or less, till December 31, 2025. It has given three months from February 11, 2025, to the small and medium pharmaceutical firms to submit their plan for upgradation to the central license approving authority in order to be eligible to qualify for Schedule M deadline extension.
The ministry said on December 28, 2023, the Centre notified revised 'Schedule M' requirements wherein ‘good manufacturing practices’ was upgraded to ‘good manufacturing practices and requirements of plan and equipment for pharmaceutical products’. Under this, manufacturers were divided into two groups with the first category of large manufacturers having turnover more than Rs 250 crore. A timeline of six months was given to such manufacturers for compliance and the revised Schedule M requirements have been implemented for these manufacturers from June 28, 2024.
For small and medium manufacturers with turnover less than or equal to Rs 250 crore, a timeline of 12 months was given for compliance. Small and medium manufacturers had represented for extension of timeline to enable improvement in infrastructure, training of personnel and arranging financial resources. It said the revised Schedule M requirements are a positive step towards ensuring the quality and safety of pharmaceutical products being manufactured in India. The new regulations would enable the pharma companies to not only strengthen their domestic position but also become more competitive globally.
